The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Rembrandt Porcelain Tinting Kit.
| Device ID | K864346 |
| 510k Number | K864346 |
| Device Name: | REMBRANDT PORCELAIN TINTING KIT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Contact | Robert Ibsen |
| Correspondent | Robert Ibsen DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-04 |
| Decision Date | 1987-01-07 |